MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD BLUNT FILL NEEDLE WITH FILTER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number 305211

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: two photos were provided for evaluation.One photo shows five packaging blister with top web 305180 lot# 9296487.The other photo shows one shelf box with the printed catalog number 305211 and the case label of 305211 lot# 9297863.The lots were produced at different times.The batch record has no documentation for issues experienced while producing them.Based on the photos provided, they are two different packaging labels ¿ packaging top web blister.It is unknown where they got mixed since the batch records have no indication of any issue experienced while producing them.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 9297863 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Based on the investigation and the analysis of the photos provided, the symptom reported by the customer is confirmed.This is the 1st complaint to this lot#.We will continue monitoring the complaints for this lot# and product.Root cause description: based on the photos provided, they are two different packaging labels ¿ packaging top web blister.It is unknown where they got mixed since the batch records have no indication of any issue experienced while producing them.Rationale: capa not required at this time.

Event Description

It was reported that the box of bd¿ blunt fill needles with filter, material 305211, batch 9297863, contained 100 units of material 305180, batch 9296487 blunt fill needles.This was discovered before use.The following information was provided by the initial reporter: i¿m writing to communicate you about a critical finding: during the packaging activities in our plant, we have found a box related to the product "blunt fill needle with filter 18gx1 1/2¿ ref.305211 containing 100 units of ¿blunt fill needle¿ ref.305180 batch 9296487.

• Brand Name: BD BLUNT FILL NEEDLE WITH FILTER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10273447
• MDR Text Key: 199899339
• Report Number: 1911916-2020-00648
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903052111
• UDI-Public: 30382903052111
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305211
• Device Catalogue Number: 305211
• Device Lot Number: 9297863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other